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临床试验/NCT03347305
NCT03347305Unknown不适用

Study in Calorimetric Room of the Energy Metabolism of Renal Impairment Patients Treated With Automated Peritoneal Dialysis

University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2016年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
24
试验地点
2
主要终点
Energy expenditure measured by indirect calorimetry in a calorimetric chamber

研究概览

简要总结

The daily energy expenditure of patients treated with peritoneal dialysis could be increased compared to the general population and promote the development of a state of undernutrition. Conversely, the absorption of glucose by transperitoneal route could contribute to the occurrence of a metabolic syndrome.

The main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber.

详细描述

The daily energy expenditure of patients treated with peritoneal dialysis could be increased compared to the general population and promote the development of a state of undernutrition. Conversely, the absorption of glucose by transperitoneal route could contribute to the occurrence of a metabolic syndrome.

The main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

盲法说明

No masking

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients Group DPA
  • Male patients
  • Aged 18 to 70 years
  • With end-stage renal disease
  • Treated by automatic peritoneal
  • Social security cover
  • Without acute events in the 3 months prior to inclusion
  • PCR < 30 mg/L
  • Written informed consent
  • Baecke activity score from 5 to 10
  • Healthy Volunteers
  • Male patients
  • Aged 18 to 70 years
  • Patients matched by lean body mass (± 2 kgs) and age (± 5 years)
  • Having a glomerular filtration rate estimated with the formula CKD-EPI creatinine > 60 mL / min / 1.73 m 2
  • PCR < 3 mg/L
  • Social security cover
  • Written informed consent
  • Baecke activity score from 5 to 10

排除标准

  • • - Female
  • Type 1 or 2 diabetes requiring a antidiabetic treatment
  • Decompensated heart failure
  • Smoking more than 5 cigarettes a day
  • Alcoholic patients, drinking more than 3 glass of alcohol a day
  • Patient Corticotherapy in progress
  • Patient with evolutive acute pathology
  • Person who has participated in another study within the last 30 days or is in period of exclusion on the National File of Healthy Volunteers

研究组 & 干预措施

Patients Group DPA

Experimental

The main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber

干预措施: automated DP (Behavioral)

Healthy Volunteers

Experimental

The main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber

干预措施: Calorimetric chamber (Behavioral)

结局指标

主要结局

Energy expenditure measured by indirect calorimetry in a calorimetric chamber

时间窗: at day 1

Energy expenditure measured by indirect calorimetry in a calorimetric chamber

次要结局

  • Actimetry(at day 1)
  • respiratory quotient (RQ)(at day1)
  • HGPO(at day 1)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (2)

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